Category Archives: GLP-1RA

Medtronic CY Q3 ’23 (FY Q2 ’24) Earnings; Lilly to Build Production Plant in Germany; Lilly Initiates Ph1 T2DM Study; Carmot Files for IPO

Four cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’23 (FY Q2 ’24) earnings call (press release; slides); Lilly announced plans to build a $2.5B production plant in western Germany to support diabetes/obesity supply (view press release); Lilly initiated a Ph1 study evaluating an unknown compound (LY3938577) vs. insulin degludec (view CT.gov record); and Carmot Therapeutics has filed for an IPO (view SEC filing). Below, FENIX provides highlights and insights for the respective items.

This content is for Read Less members only.
Register
Already a member? Log in here

Zepbound (tirzepatide) Label and Website Analysis

FDA recently approved Lilly’s tirzepatide, branded as Zepbound, for the treatment of adults who are obese or overweight with weight-related comorbidities such as hypertension, T2DM, OSA, or CVD (view label; previous FENIX insight). Below, FENIX has conducted a Zepbound label, website, and pricing analysis, including thoughts on Lilly’s innovative targeting of employers.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo Initiates Ph2 Cagrisema Trial in CKD and T2DM; Carmot Initiates Ph2 GLP-1/GIP RA Study in Obesity and T1DM; OptumRx Lowers Insulin Costs; Beta Bionics Gains Coverage for iLet Bionic Pancreas; Mark Estes Joins Biolinq; Belgium and Britain Ban Ozempic for Weight Loss

A series of cardiometabolic-related news items have been observed from Novo, Carmot Therapeutics, OptumRx, Beta Bionics, and Biolinq. Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo H2H Cagrisema vs. Tirzepatide Trial; Terns and Nemaura Q3 ’23 Earnings; Viking Ph2b MASH Data at AASLD; SAB Therapeutics Raises $67.1M for T1DM Treatment; Dexcom Launches #SeeDiabetes Campaign

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Terns Pharmaceuticals, Nemaura, Viking, SAB Therapeutics, and Dexcom. Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo SELECT AHA 2023 Investor Event

Novo Nordisk hosted a post-SELECT data readout investor event during AHA 2023 (view webcast). During the call, Novo reviewed the full SELECT results and provided additional commentary on the data. In case you missed it, FENIX recently conducted an analysis on the SELECT market implications (view here). Below, FENIX provides highlights and insights from the Novo AHA 2023 investor event.

This content is for Read Less members only.
Register
Already a member? Log in here

SELECT Lives Up to the Hype; Full SELECT Results at AHA 2023

Novo Nordisk announced positive full results from the SELECT CVOT (view CT.gov record) demonstrating a -20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg semaglutide (Wegovy). The full results were presented at AHA 2023 and simultaneously published in the NEJM (view publication). Recall, SELECT was filed with US and EU regulators in September and October 2023, respectively, and FDA has granted priority review with a PDUFA date projected in March 2024 (previous FENIX insight). Below, FENIX provides thoughts on the SELECT results, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.

This content is for Read Less members only.
Register
Already a member? Log in here

Lilly’s Mounjaro Receives Positive CHMP Opinion for Obesity; Lilly at UBS 2023; Novo Expands Existing Manufacturing Facilities; Madrigal Appoints Carole Huntsman as CCO; Madrigal, Akero, and Boston Present MASH Data at AASLD 2023; Diabetes Care Survey Results

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Madrigal, Akero, Boston Pharmaceuticals, and Smart Meter. Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

AZ Buys Oral GLP-1RA; Q3 ’23 Earnings Update

AstraZeneca hosted its Q3 ’23 earnings call (press release; slides) and provided updates to its CVRM business, including insight on its newly acquired oral GLP-1RA. Just prior to the earnings release, AZ announced it entered into an exclusive licensing agreement for ECC5004, a QD oral GLP-1RA, from Eccogene (view press release). Below, FENIX provides highlights and insights from the call, including thoughts on AZ’s decision to acquire the new oral GLP-1RA.

This content is for Read Less members only.
Register
Already a member? Log in here

Tirzepatide Obesity Indication Approved as “Zepbound” 

Lilly announced that FDA approved tirzepatide as “Zepbound” for adults with obesity or overweight that also have weight-related comorbidities such as hypertension, dyslipidemia, T2DM, OSA, or CVD (view label). Of note, FDA also made an announcement regarding the approval (view here). Tirzepatide remains under review in the EU, UK, China, and other markets. Lilly stated Zepbound is anticipated to be launched in the US by EOY 2023 in six doses (2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg). In the press release, Lilly specifically disclosed the Zepbound WAC price of $1,059.87, which Lilly noted is 20% less expensive than Wegovy. FENIX will conduct a full label analysis of Zepbound in the coming days.

This content is for members only.
Register
Already a member? Log in here